Thursday, September 28, 2023
Smart Immune, a clinical-stage biotechnology company focusing on the development of ProTcell, a T-cell progenitor therapy platform designed to swiftly rejuvenate the immune system, has officially initiated its ReSET-02 Phase I/II trial for adult acute leukemia and myelodysplasia syndrome patients.
In this trial, two patients have received the initial dosage of SMART101, an allogeneic cell therapy derived from donor mobilized peripheral blood stem cells and then differentiated into T-cell progenitors using Smart Immune's ProTcell therapy platform. Early data indicate that SMART101 is well-tolerated and exhibits a safety profile consistent with what has been observed in patients enrolled in the ongoing ReSET-01 clinical trial involving T-cell-depleted allogeneic HSCT. Over the upcoming weeks, more patients are expected to receive dosages, with a total of 40 patients slated for enrollment.
The ReSET-02 trial (NCT05768035) is an open-label, multi-center Phase I/II study aimed at assessing the safety and effectiveness of SMART101 following standard-of-care HSCT with post-transplant cyclophosphamide in adult patients diagnosed with hematological malignancies, including acute lymphoid leukemia, acute myeloid leukemia, and myelodysplasia syndrome. The primary objective is to expedite T-cell reconstitution to combat relapse and infection, ultimately improving overall survival and disease-free survival post-transplant.
Should the trial prove successful, it could accelerate the validation of Smart Immune's ProTcell platform, which holds potential applications beyond oncology, including potential use in treating HIV.
SMART101 has been granted Orphan Drug Designation (ODD) by both the European Medicines Agency and the US Food and Drug Administration (FDA), in addition to Fast Track Designation by the FDA, as a treatment aimed at enhancing cell engraftment in patients undergoing HSCT. SMART101 is manufactured at the MEARY Center, AP-HP, located in Paris.
Karine Rossignol, CEO of Smart Immune, expressed her excitement, stating, "We are thrilled to have initiated our trial to evaluate SMART101 in the standard-of-care haploidentical setting. Our objective is to demonstrate our ability to rapidly and effectively reinvigorate the immune system, ultimately enhancing survival rates in challenging-to-treat cancers by harnessing the thymus to provide a new immune system within a matter of months."
Frédéric Lehmann, Chief Medical Officer of Smart Immune, added, There is a significant unmet medical need for a widely accessible and well-tolerated therapy for immune-compromised patients with hematological malignancies post allogeneic transplant. Administering these initial doses of SMART101 to two leukemia patients represents the initial step toward potentially addressing this long-standing medical challenge. Based on our preclinical data, we believe our thymus-empowered allogeneic cell therapy has the potential to redefine treatment approaches and enhance clinical outcomes in allogeneic HSCT. We extend our heartfelt gratitude to the participating patients, clinical sites, and our dedicated teams for their ongoing commitment to this important endeavor.
